Rebiscan, Inc.: FDA clearances and approvals
Rebiscan, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel. openFDA lists 1 product recall by a recalling firm named Rebiscan, Inc. It is the industry lead sponsor of 9 device clinical trials on ClinicalTrials.gov.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| PMW | Strabismus Detection Device | 1 | 0 |
Review panels
- Ophthalmic (1)
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN130051 | De Novo | Strabismus Detection Device | 2016-06-08 |
Recalls
1 product recalls in 1 recall events; 1 initiated in the last five years. Most recent: 2022-10-03.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Rebiscan, Inc. is the industry lead sponsor of 9 device studies on ClinicalTrials.gov (3 active or recruiting). Most recent:
- NCT06142435: mTBI Identification and Monitoring Through Retinal Scanning (Recruiting, started 2023-08-15)
- NCT05092295: Head and Intraocular Trauma Tool for the Identification of Mild Traumatic Brain Injury (Active not recruiting, started 2021-12-01)
- NCT05092282: HITT for the Identification of Mild Traumatic Brain Injury (Active not recruiting, started 2021-08-01)
- NCT03653936: Neuro-ocular Baselines in a Sports Setting (Completed, started 2018-04-01)
- NCT03249818: HITT Device Pilot Testing for Traumatic Brain Injury (Completed, started 2017-08-22)
Frequently asked questions
How many FDA 510(k) clearances does Rebiscan, Inc. have?
Rebiscan, Inc. has 0 FDA 510(k) clearances, plus 1 De Novo decision, across 1 product code in 1 review panel.
What devices does Rebiscan, Inc. make?
Its most frequent FDA product codes are PMW (Strabismus Detection Device, 1).
Has Rebiscan, Inc. had device recalls?
openFDA lists 1 product recall in 1 recall event by a recalling firm whose name matches Rebiscan, Inc; the most recent began 2022-10-03. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 0 Rebiscan, Inc. clearances with predicates and recalls
- Run predicate analysis for product code PMW, Rebiscan, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.